Attachment Ca. Instructions for Completing State and County Representative Spreadsheet Instrument
XDR TB Contact Investigation: A Cost Assessment
Form Approved
OMB No. 0920-0879
Expiration Date 03/31/2018
Introduction
After arriving to the United States in April 2015, a person with infectious extensively drug resistant tuberculosis (XDR-TB) came into contact with people who were identified and followed across 14 states. While previous analyses have estimated the economic value of conducting contact investigations of TB after exposure during long airline flights [1], among refugee populations [2], and different models of conducting contact investigations [3]; and epidemiological studies on large contact investigations are available [4, 5]; studies on the costs of investigating large numbers of people having contact with XDR-TB patients across multiple jurisdictions are needed.
This assessment is important for several reasons. Making estimates as setting-specific as possible can inform projections or evaluations of responding to XDR cases in the future for the jurisdictions involved [6]. Therefore, the Centers for Disease Control and Prevention (CDC) is gathering data to evaluate the cost of the contact investigation for this recent XDR-TB case from a ‘bottom-up perspective’, reflecting the cost of what actually occurred. In addition, this assessment can be used to check whether general estimates from previous studies can be used to predict costs accurately, or if ‘bottom-up perspective’ activities add value. We anticipate that both the research process and results will raise awareness about the cost of contact investigations, and activities will provide a spreadsheet template that can be used to estimate the cost of contact investigations in the future.
Objectives include:
1. Collect or estimate the overall direct costs of investigating and following contacts of an imported XDR tuberculosis patient
2. Collect or estimate the direct costs to tuberculosis programs in affected states and other entities involved
3. Provide results that will be used by CDC, state, and local programs
Methods
This assessment will use data on the costs to the health system of this contact investigation up to this point, and model the total cost up to two years for the remaining analytic horizon. Data collection will involve identifying types of resources used to conduct the investigation, quantifying the number of units or time consumed, and assigning a monetary value to each of them [7]. The total cost of the contact investigation will then be calculated, and state-specific and organization-specific subtotals will be generated.
Short description of questions
Activities to be evaluated include the costs of organizing and managing the investigation, finding contacts, testing them, treating them, and following them up. We are asking for the following data about the contact investigation specific to your location:
A few statistics describing investigation outcomes
Number and types of tests administered for TB infection and disease and results
Risk factors for developing TB disease after infection
Costs of testing for TB infection and disease
Costs of testing for other illnesses that are risk factors for TB
Costs of treating latent tuberculosis infection (LTBI)
Personnel costs
Travel costs
Training costs
Costs of incentives and enablers
Any other miscellaneous costs necessary for this XDR TB contact investigation
Please include all relevant items consumed regardless of who paid for them, although indicating who if information is available. If the item was donated, please include it in the total. We are not collecting data that identify specific people. However, we need the following aggregate data to compute costs and adequately describe the contact investigation that occurred.
Excel worksheet
An Excel worksheet with two tabs at the bottom is provided to record these costs for two phases (1) preparatory and initial assessments in identifying and evaluating each contact up to their initial diagnosis and classification, and (2) follow-up costs to date. We will use this information to project the costs that will be expected for the two-year time horizon of the investigation. If you expect any deviations from standard protocols between now and the two-year endpoint, please let me know. If more rows are needed to insert data anywhere on the spreadsheet to fit your data, please insert them. If an estimate is unknown or uncertain, please make your best estimate. If needed, you can indicate a range of values. If an item or category is ‘not known’, ‘not recorded’, or ‘not relevant’; please indicate with the appropriate phrase to indicate to us that nothing has been overlooked. Line numbers corresponding to the accompanying spreadsheet are included in parentheses; it may be helpful to save a blank copy of the spreadsheet for your records if you decide to fill in a copy.
Actual
data collection
Who should answer these questions?
These questions are intended for anyone from the TB controller’s office who can collect and/or report data to the CDC. Potential respondents may include nurses, program managers, accountants, contact investigators, epidemiologists, interjurisdictional referral contacts, nurse consultants, nurse case managers, surveillance managers, public health program specialists, or anyone else who is delegated by the TB controller.
Time burden
Please review the accompanying spreadsheet and following questions about data that we will be collecting. This data collection should take about 1 hour to review instructions per person, 2 hours to collect data (or 1.5 hours for the first person, 30 minutes for the second), with another 1.5 hours to transmit the data to the master CDC spreadsheet or discuss results with the analyst via phone interview (1 hour for the first person, 30 minutes for the second). After all results are together, the analyst will schedule another call to follow-up for any new developments and ask any questions about the data (20 minutes each).
Preparation and initial assessments page
Please provide data for activities spent in preparation for the contact investigation and assessments of each contact to the point in which you determine results from preparation and initial assessments up to their initial diagnosis and classification. Before completing the form, it may be helpful to save a blank copy of the file to ensure that line numbers correspond to questions as you may need to add rows so that your data will fit.
I will already have information describing your location (lines 12-14)
Please tell us some specifics about contact evaluation outcomes (lines 18-25)
How many hours in total were needed to identify contacts in your state?
Please include time of personnel directly involved in contact investigation activities, in addition to administrative and support staff
How many contacts were identified in your state?
This response will validate my records
Please include both air and ground; and high, medium, low priority; or 'close and casual contacts' if you have used that classification
By classification, how many high, medium, and low priority contacts were identified [8]?
How many contacts were classified as either high priority [8] or ‘close contacts’ [9]?
High-priority contacts include the following [8].
Household contacts
Under 5 years old
With an immunosuppressive medical risk factor (HIV, diabetes, silicosis, gastrectomy or jejunoileal bypass surgery; or taking prednisone, chemotherapy, antirejection drugs, or TNF alpha inhibitors)
Exposed during a medical procedure (bronchoscopy, sputum induction, autopsy)
Exposed in a congregate setting
Exposed for more than locally defined environmental duration limits for high priority
Close contacts is an older, less specifically defined, classification, including contacts with prolonged, frequent, or intense contact with a TB case while infectious
How many contacts were classified as medium-priority contacts?
Medium-priority contacts include the following [8].
Between 5-15 years old
Exposed for more than locally defined environmental duration limits for medium priority
How many contacts were classified as low-priority or casual contacts?
Low priority contacts are all contacts that are not classified in the other two categories
Casual (other than close) contacts have less intense, less frequent, or shorter durations of contact with the TB case while they are infectious.
How many contacts in your state were evaluated for TB?
Please include both LTBI and TB disease evaluations
How confident are you that this number represents the total number of actual contacts exposed to the index case?
Please indicate high, moderate, or low, and comment on any areas of uncertainty
What were the results of testing for tuberculosis infection and disease, indicating the number of tests administered, and those whose result was positive, negative, and indeterminate? Please indicate any notes needed for explanation in column I, such as a borderline result (lines 29-41).
Tuberculin skin testing
Initial tuberculin skin test (TST) placement with TB education
Reading of initial TST
IGRA testing
QuantiFERON Gold In Tube (QFT-GIT) interferon gamma release assays (IGRA)
T-spot IGRAs
Testing for TB disease
Physical examinations
Chest x-ray (CXR)
Sputum induction
Sputum smear microscopy and culture exams
Nucleic acid amplification (NAA) tests for TB disease
How many contacts had the following risk factors for developing TB disease after infection? Please include any explanatory notes as needed in column F (lines 45-82).
How many contacts were born in the different regions listed?
Please indicate ‘other’ if the contacts were born in a low incidence region.
There is a space for notes if any explanation is needed. For example, if the contact was born to at least one US born parent living in another country.
How many contacts have lived or travelled for more than one month in the different regions listed?
Please indicate ‘other’ if the contacts lived or travelled in a low incidence region.
There is a space for notes if any explanation is needed.
How many contacts had medical risk factors?
How many contacts had a history of LTBI prior to investigation?
How many contacts had a history of TB disease prior to investigation?
How many contacts had received the BCG vaccine?
How many contacts had diabetes?
Please include both type I and type II diabetes.
How many contacts had HIV or AIDS?
Please include documented laboratory or clinical diagnosis, or indicate unknown. Self-report is not sufficient [10, 11].
How many contacts had autoimmune disease or another immunosuppressive condition?
How many contacts had non-medical risk factors?
How many contacts were close contacts of someone with TB disease other than the index case?
How many contacts were under 5 years old?
If day, month, or year of birth are unknown, please report according to the level of information that is available [11].
How many contacts were a resident of a correctional facility in the past year?
Please include prison, jail, juvenile, or any other type of correctional facility [11].
How many contacts used injection drugs in the past year?
Please include having ever used injecting drugs including people classified by either documented and physical evidence [11].
How many contacts were homeless in the past year?
Homelessness is defined as having no fixed, regular, and adequate nighttime residence, or living in a shelter, temporary institution, unstable residence, or public or private place not designated for a regular sleeping accommodation of human beings [11].
What were the costs of the testing for TB infection and disease? (lines 86-94)
Please note that this and the following two blocks of questions ask about the costs according to the number of services provided, not data according to the number of contacts. In contrast, the previous three blocks of questions ask for data according to number of contacts.
Please indicate the unit costs for the following tests (Column E)
Tuberculin skin tests (TST)
QuantiFERON Gold In Tube (QFT-GIT) IGRAs
T-spot IGRAs
Physical examinations
Chest x-rays (CXR)
Sputum inductions
Sputum smear and culture exams
Nucleic acid amplification (NAA) tests
Please indicate who paid for them (Column F)
Please list any notes or specifications about the type of service (Column G)
For example, different types of CXR may be used in different circumstances
Different NAA tests may use different polymerase chain reaction (PCR) methods, probes, or sequencing methods.
What testing was provided for illnesses that are risk factors for TB disease, including HIV, diabetes, severe kidney disease, or any other condition? (lines 98-113)
ELISA (HIV)
Western blot (HIV)
Rapid diagnostic test (HIV)
Hemoglobin A1C test (Diabetes)
Blood glucose test (Diabetes)
Urinalysis (Kidney disease)
Ultrasound (Kidney disease)
Computerized tomography (Kidney disease)
Biopsy (Kidney disease)
Any other test
How many tests were provided? (column E)
What was the cost per service? (column F)
Who paid for these services? (column G)
Please give any explanatory notes at the end (column H)
Please repeat for each service provided, including any other tests administered that are not listed.
Please note that counselling services provided to contacts about these conditions is included as part of personnel costs.
What costs of treating latent tuberculosis infection (LTBI) were incurred? (lines 117-121)
How many contacts were initiated on treatment for potentially drug susceptible tuberculosis with 6H, 9H, 4H, or 3HT? (column E)
What was the cost per dose? (column F)
How many doses were taken? (column G)
Who paid for it? (column H)
How many contacts were treated incorrectly with Cycloserine (CYC)? (column E)
What was the cost per dose? (column F)
How many doses were taken? (column G)
Who paid for it? (column H)
Please indicate any other notes in column I.
What investigative, clinical, administrative, laboratory, government, or other personnel were involved in the contact investigation? (lines 126-161)
Please provide aggregate data
Please exclude clinician time used for physical examinations. These costs are accounted for in Section 5.
How many total personnel were involved in the contact investigation by category? (column E)
Please include personnel involved directly in the specific XDR-TB contact investigation, and administrative or support personnel who also contributed their time.
If one person filled more than one role, please divide their time according to role.
How many total hours were spent on activities related to or supporting the contact investigation? (column F)
Please account for activities preparing for the investigation as well as investigation activities themselves such as interviewing or counselling contacts, coordinating with others in the contact investigation team, and time spent in training or self-study.
Please also include donated time.
Please round hours to the nearest quarter hour.
What was the average gross annual salary (without benefits)? (column G)
What was the percent fringe benefit involved from your jurisdiction? (column H)
Who paid for the salaries? (column I)
Please indicate any notes needed (column J)
Please add any other categories at the end
What travel costs did your office incur in preparing for the investigation (e.g. meetings), and in locating, interviewing, and testing contacts? (lines 166-173)
If travel included objectives external to activities related to the contact investigation, please indicate only the expenses that would have been incurred on the contact investigation activities alone. For example, do not include the costs of returning home if the contact investigator forgot something unrelated to the project. However, things that are necessary and typical for program activities to function, such as going to the gas station, should be included.
What were the mileage costs?
Were per diem costs incurred?
Per diem costs include lodging, meals, incidental expenses incurred when traveling
Were any other types of travel costs related to contact investigation activities incurred?
Please list any notes in column H.
Did anyone involved in the contact investigation receive any training that contributed to their ability to perform this specific contact investigation [12]? (lines 177-185)
Please list all trainings in column D that were specific to this contact investigation.
Please list all personnel categories of participants who were involved in the contact investigation separately as subheadings in column D if any of the following information.
How many personnel of each category received the training in total? (column E)
How many personnel receiving the training were involved in contact investigation activities, administration, or support? (column F)
What was the cost of providing each training course? (column G)
Each training course may involve multiple sessions. Please account for each course as one training
Please include time and salary costs of the instructor and participants under personnel if all were in-house. If an external instructor provided the training, please include their time and salary costs here.
Please include any food or materials consumed such as printed manuals, presentation materials, contact investigation supplies, or any other components
How long is the training valid for before it would be renewed? (column H)
What proportion of the person’s job responsibilities helped by this training is dedicated to the contact investigation or its support? (column I)
Who provided the training? Was it external or in-house? (column J)
Please indicate if the training was with a Regional Training and Medical Consultation Center, with the CDC, or other organization to help us avoid double counting.
Who paid for the training? (column K)
Please list any notes in column L
Please indicate the types and quantities of incentives and enablers that were used for contact investigation activities, and how much they cost (lines 189-195)
Incentives include things that encourage the person to keep their appointments
Enablers include things to help the person keep their appointments
Please list specific items in column D
How many units were consumed? (column E)
What was the cost per unit? (column F)
Who paid for them? (column G)
Please add any notes in column H
Please indicate any other miscellaneous costs incurred during preparation or for contact investigation activities and initial assessments that were not included in previous sections (lines 199-203)
Please list specific items in column D
How many units were consumed? (column E)
What was their cost per unit? (column F)
What percentage of each resource was dedicated to contact investigation activities? (column G)
Who paid for each item? (column H)
Please add any notes in column I
Follow-up activities conducted
For the same categories listed above for the preparation period and initial assessment, please indicate what resources have been consumed in the follow-up phase to the current date on the second tab. This period includes cost of physical examinations and diagnostic testing (periodically and as needed), cost of LTBI treatment, personnel costs, travel costs, training costs, costs of incentives and enablers, and any other costs. I will use data from this page to make projections about what the contact investigation will cost across its two-year time horizon. On this page, please be specific in quantifying all components consumed. If valuations are the same as in the initial period, it is fine to simply indicate ‘same’, and I will transfer the valuations from the initial sheet.
Contact information
If you need clarification about what any of these questions mean or what is needed, please do not hesitate to contact us (Samuel Shillcutt at 404-718-8963 [email protected], and Suzanne Marks at [email protected]). We would request that you contact us by (date TBD after decision by OMB) to set up a call to record the data that you have collected. Thank you very much for your collaboration!
References
1. Coleman, M.S., et al., Economics of United States tuberculosis airline contact investigation policies: A return on investment analysis. Travel medicine and infectious disease, 2014. 12(1): p. 63-71.
2. CDC, Multidrug-resistant tuberculosis in Hmong refugees resettling from Thailand into the United States, 2004-2005. MMWR. Morbidity and mortality weekly report, 2005. 54(30): p. 741.
3. Pisu, M., et al., Targeted tuberculosis contact investigation saves money without sacrificing health. Journal of public health management and practice: JPHMP, 2009. 15(4): p. 319.
4. Collins, J., S. Schlager, and E. Brasher, Contact investigation of a case of tuberculosis. American journal of infection control, 2004. 32(1): p. 38-43.
5. Kaiser, C., et al., Rapid large-scale deployment of tuberculosis testing in a high school-riverside county, california, 2013-2014. MMWR. Morbidity and mortality weekly report, 2015. 64(21): p. 574-577.
6. CDC, Plan to combat extensively drug-resistant tuberculosis: recommendations of the Federal Tuberculosis Task Force, in MMWR. 2009, Centers for Disease Control Prevention: Atlanta GA.
7. Haddix, A.C., S.M. Teutsch, and P.S. Corso, Prevention effectiveness: a guide to decision analysis and economic evaluation. 2003, New York: Oxford University Press.
8. CDC, Guidelines for the investigation of contacts of persons with infectious tuberculosis. Recommendations from the National Tuberculosis Controllers Association and CDC. MMWR, 2005.
9. CDC, Module 6: Self-Study Modules on Tuberculosis. Contact Investigations for tuberculosis. 1999, Centers for Disease Control and Prevention: Atlanta. p. 130.
10. CDC, Appendix: Revised surveillance case definition for HIV infection. MMWR, 1999. 48(RR13): p. 29-31.
11. CDC, Report of verified case of tuberculosis (RVCT): Self study modules participant manual. 2009, Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepititis, STDs, and Tuberculosis Prevention: Atlanta.
12. Wilce, M., et al., Tuberculosis contact investigation policies, practices, and challenges in 11 US communities. Journal of Public Health Management and Practice, 2002. 8(6): p. 69-78.
CDC estimates the average public reporting burden for this collection of information as up to 2.5 hours per response per program manager and 1.5 hours per response per accountant, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0879).
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Shillcutt, Samuel (CDC/OID/NCHHSTP) |
| File Modified | 0000-00-00 |
| File Created | 2021-01-26 |